MedTrace Logo

Cerebral Oxymetry and Neuronal Markers in Newborns and Infants Undergoing Surgery

NCT02423369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-12-15

No results posted yet for this study

Summary

The purpose of this study is to assess whether peri-operative period in neonates and infants is associated with an increase in blood biomarkers, specific for neuronal injury, and to correlate them with clinical variables and sedative/analgesic agents. Patients, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and postoperative treatment, including analgesia and sedation, are given as per standard of care.

Conditions

  • Peri-operative Injury
  • Newborn, Infant, Disease

Interventions

PROCEDURE

Cerebral near infrared spectroscopy

At the start of anesthesia on the patient's forehead two electrodes are attached the for continuous measurement of cerebral near infrared spectroscopy during surgery.

OTHER

S-100B protein in serum

0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.

OTHER

NSE protein in serum

0,5-1 ml of blood from periferal site for determination of serum NSE concentration.

Sponsors & Collaborators

  • Research Council of Lithuania

    collaborator OTHER

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Danguole C Rugyte, MD. PhD · Lithuanian University of Health Sciences

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
93 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Lithuania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423369 on ClinicalTrials.gov